Medical Governance, Evidence & Ops Manager

The Medical Governance, Evidence & Ops Manager is a strategic leadership role responsible for driving the highest standards of medical excellence, medical governance, and operational excellence across Medical Affairs activities to ensure optimal patient outcomes.

This role serves as a key enabler of compliant, efficient, and patient-centric medical execution by establishing robust governance frameworks, driving evidence generation strategies, and optimizing medical operations aligning with medical strategies.

The successful candidate will work closely with Medical Affairs, Regulatory, Legal, Ethics & Risk Compliance (ERC), Quality, Safety, and cross-functional partners to ensure alignment with Novartis standards, local regulations, and global Medical Affairs priorities.

Major Accountabilities:

• Medical Capabilities, Governance & Compliance:

+ Drive medical capability training plans, including AI and governance education. + Lead implementation and maintenance of local medical governance frameworks. + Ensure compliance with Novartis Good Practices, local regulations, SOPs, and global Medical Affairs standards.

• Evidence Generation Strategy & Oversight:

+ Support development and execution of country evidence generation plans aligned with medical and access strategies. + Oversee local clinical studies, investigator-initiated studies (IIT), non-interventional studies (NIS), real-world evidence (RWE) initiatives, research collaboration, and Managed Access Programs (MAP).

• Medical Operations Excellence:

+ Drive simplification, harmonization, and continuous improvement of Medical Affairs processes. + Establish operational metrics, dashboards, and performance indicators.

• Overall Product Strategy and Cross-functional Collaboration:

+ Support assigned portfolio, including provision of scientific information, answering medical enquiries, and materials review. + Coordinate review and approval of medical materials and locally developed promotional materials.

Key Performance Indicators:

• Works within Ethics & Compliance policies.
• Achievement of annual targets for medical activities.
• Operational excellence metrics achieved.
• Execution of evidence generation plans.
• Study milestones delivered on time and within budget.
• Governance training completion rate.
• Audit and inspection readiness status.
• CAPA closure effectiveness.
• Stakeholder satisfaction and cross-functional collaboration effectiveness.

Requirements:

• Advanced degree in Life Sciences, Pharmacy, Medicine, Public Health, Epidemiology, or related scientific discipline.
• Master's degree, PharmD, PhD, or MD preferred.
• 2-4+ years of experience in Medical Affairs, Clinical Research, Medical Operations, Evidence Generation, Medical Governance, or related functions.
• Experience supporting or leading clinical studies, RWE programs, or evidence-generation initiatives.
• Strong understanding of GxP, medical governance frameworks, healthcare compliance standards, and local regulations.
• Experience working in a complex matrix organization.
• Knowledge of digital Medical Affairs platforms and analytics tools (preferred).

Skills:

• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.
• Capability Building Training.
• Clinical Practices.
• Clinical Research.
• Clinical Trials.
• Drug Development.
• Risk Identification and Mitigation.
• Health Sciences.
• Organization Skills.
• Patient Care.
• Stakeholder Engagement.